Posts tagged medical devices

• FDA Places New Restrictions on Guidant

  Joe Saunders | February 16, 2006 9:10 AM | 0 CommentsOrlando, FL Category: Medical Malpractice
  

  New limits imposed by the FDA on Guidant, maker of an implantable heart defibrillator found to be defective, will make it difficult for new products made by the company to be approved for commercial sale, as the agency applies pressure to the company to improve its manufacturing procedures. In the letter, sent a week ago, the agency said Guidant had not fully responded to its concerns about...

• Guidant CEO to Receive $1.5Million Bonus. . . For What?

  Joe Saunders | February 10, 2006 5:52 AM | 0 CommentsOrlando, FL Category: Medical Malpractice
  

  Guidant's chief executive will receive a $1.5 million bonus after the acquisition by Boston Scientific is complete, according to documents filed with the U.S. Securities and Exchange Commission. Since June, Guidant has recalled or issued safety advisories on about 88,000 defibrillators and more than 200,000 pacemakers. At least seven deaths have been linked to the faulty devices. I guess that...

• Boston Scientific's Mea Culpa

  Joe Saunders | February 05, 2006 10:05 AM | 0 CommentsOrlando, FL Category: Medical Malpractice
  

  Now that Boston Scientific, the maker of medical devices, has been publicly chastised by the FDA, its executives have taken a penitential tone. "It's clear we have not done enough to resolve the issues raised by the F.D.A., "a spokesman, Paul Donovan, said in a statement yesterday, "and we recognize fully that the responsibility to do so lies with us."Already, the F.D.A. has told Boston...

• FDA Sends Warning to Boston Scientific

  Joe Saunders | January 30, 2006 7:10 AM | 0 CommentsOrlando, FL Category: Medical Malpractice
  

  Boston Scientific fresh off its acquisition of Guidant Corporation, has been sent a warning letter by the FDA. Federal regulators said they discovered problems in the medical device maker's quality control. FDA officials who announced the warning involving Boston Scientific said it was only the third time in the agency's history it has issued such a broad companywide warning involving a...

• Lawyer Subpoenaed for Guidant Documents

  Joe Saunders | January 29, 2006 11:45 AM | 0 CommentsOrlando, FL Category: Medical Malpractice
  

  An attorney suing Guidant Corporation has been ordered by the Justice Department to turn over the documents he received from the company. The subpoena, part of the federal government's investigation into the Indianapolis-based company, requires Texas attorney Bob Hilliard to turn over handwritten notes and PowerPoint slides. He obtained them from the company during preparations for a product...

• Boston Scientific Medical Device Recall

  Joe Saunders | January 27, 2006 4:09 PM | 0 CommentsOrlando, FL Category: Medical Malpractice
  

  Attorney Jordan Margolis posted a nice piece on two Boston Scientific medical device recalls. Those who have had these devices should check the product information against their medical records and seek both medical and legal advice regarding these product recalls.

• Guidant's Troubles Aren't Over

  Joe Saunders | January 23, 2006 8:03 AM | 0 CommentsOrlando, FL Category: Medical Malpractice
  

  On January 19, 2006, a Texas judge ordered Guidant to hand over internal documents that might show the company continued to sell some of its heart defibrillator models after knowing that the devices might prove faulty. The NY Times reported the following day that the documents appear to show that some Guidant executives recommended in January 2005 that perhaps the company should find a way to...

• Guidant Withholds Info About the Dangers of its Defibrillators

  Joe Saunders | December 28, 2005 1:43 PM | 0 CommentsOrlando, FL Category: Medical Malpractice
  

  In documents filed in a Texas lawsuit against Guidant, the manufacturer of implantable defibrillators, the company failed to disclose publicly that Guidant officials had projected that some patients might die because of short circuits in their implantable defibrillator. According to the documents, Guidant did not disclose the information because the overall failure rate was not worthy of public...

• Guidant Heart Device Blamed for 3 More Deaths

  Joe Saunders | December 15, 2005 6:58 AM | 0 CommentsOrlando, FL Category: Medical Malpractice
  

  According to an article published in the Minneapolis-St. Paul Business Journal Guidant heart devices have been linked to three new deaths. The information arose out of a Guidant report to the US Food and Drug Administration. The deaths occurred after Guidant had recalled the devices in June.